The proliferation of digital technologies and the application of sophisticated data analysis techniques are increasingly viewed as having the potential to transform translational research and precision medicine. While digital technologies are rapidly applied in innovative ways to develop new diagnostics and therapies, the ultimate approval and adoption of these emerging methods presents several scientific and regulatory challenges. To better understand and address these regulatory science gaps, a working group of the Clinical and Translational Science Awards Program convened the Regulatory Science to Advance Precision Medicine Forum focused on digital health, particularly examining gaps in the use, validation, and interpretation of data from sensors that collect and tools that analyze digital biomarkers. The key findings and recommendations provided here emerged from the Forum and include the need to enhance areas related to data standards, data quality and validity, knowledge management, and building trust between all stakeholders.

中文翻译：

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将数字健康技术转化为推进精准医学：为监管科学提供信息

数字技术的普及和复杂数据分析技术的应用越来越被视为具有改变转化研究和精准医学的潜力。虽然数字技术以创新的方式迅速应用以开发新的诊断和疗法，但这些新兴方法的最终批准和采用提出了一些科学和监管挑战。为了更好地理解和解决这些监管科学差距，临床和转化科学奖计划的一个工作组召开了监管科学推进精准医学论坛，重点关注数字健康，特别是检查传感器数据的使用、验证和解释方面的差距收集和分析数字生物标志物的工具。